Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Recruitment period: From February to August 2009.79 healthy adult volunteers from 18 to 40 years of age were selected. Participants were screened for eligibility and enrolled by the investigators following the signing of an informed consent. Due to a recommendation from ANVISA, female volunteers were not allowed to be recruited.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

98 potential volunteers were interviewed, 80 of them were enrolled: 40 volunteers were allocated to receive the investigational product (rotavirus vaccine) and 40 were allocated to receive placebo; 79 completed the follow-up. Before randomization 18 volunteers were excluded, 3 refused to participate and 15 had screening failure

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

In the vaccine gorup one volunteer was not considered for the final analysis because He received the second dose of the vaccine in an anapropriate interval.